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Mini Oral - Gynaecological cancers 2

812MO - Maintenance olaparib + bevacizumab (bev) in patients (pts) with newly diagnosed advanced high-grade ovarian cancer (HGOC): RECIST and/or CA-125 objective response rate (ORR) in the phase III PAOLA-1 trial


18 Sep 2020


Mini Oral - Gynaecological cancers 2



Tumour Site

Ovarian Cancer


Nicoletta Colombo


Annals of Oncology (2020) 31 (suppl_4): S551-S589. 10.1016/annonc/annonc276


N. Colombo1, J. Gantzer2, B. Ataseven3, C. Cropet4, G. Scambia5, A. Herrero6, P. Sevelda7, H. Kobayashi8, P. Vuylsteke9, M.R. Mirza10, F. Priou11, P. Buderath12, C. Pisano13, N. Lainez14, C. Guillemet15, A. Burges16, R. Sverdlin17, A. El-Balat18, N. Raban19, I.L. Ray-Coquard20

Author affiliations

  • 1 Gynecologic Oncology Department, University of Milan-Bicocca and European Institute of Oncology IRCCS, 20141 - Milan/IT
  • 2 Ccu-ah Oncologie Médicale, Hôpitaux Universitaires de Strasbourg and ICANS, Strasbourg/FR
  • 3 Department Of Gynecology And Gynecologic Oncology, Evang. Kliniken Essen-Mitte, 45136 - Essen/DE
  • 4 Direction De La Recherche Clinique Et De L’innovation (drci), Centre Léon Bérard, 69373 - Lyon/FR
  • 5 Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 - Roma/IT
  • 6 Medical Oncology, Miguel Servet University Hospital, Zaragoza/ES
  • 7 Gynecological And Obstetric Department, Krankenhaus Hietzing Wien, Vienna/AT
  • 8 Department Of Obstetrics And Gynecology, Kagoshima University Hospital, Kagoshima/JP
  • 9 Medical Oncology Department, CHU UCL Namur Site St Elisabeth, Namur/BE
  • 10 Department Of Oncology, Rigshospitalet - Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 11 Internal Medicine Department Hemato-oncology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 12 Department Of Gynecology And Obstetrics, Universitätsklinikum Essen, 45147 - Essen/DE
  • 13 Department Of Urology And Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples/IT
  • 14 Medical Oncology Department, Complejo Hospitalario de Navarra, 31008 - Pamplona/ES
  • 15 Gynecological Cancers, Centre Henri Becquerel, 76038 - Rouen/FR
  • 16 Ago, Klinikum der Universität München, Munich/DE
  • 17 Cancerology, Groupe Hospitalier Saint-Joseph, Paris/FR
  • 18 Department Of Gynecology And Obstetrics, Klinikum der Johann Wolfgang Goethe-Universität, 60590 - Frankfurt am Main/DE
  • 19 Medical Oncology Department, Hôpital de la Milétrie - CHU de Poitiers, Poitiers/FR
  • 20 Medical Oncology Department, Centre Léon Bérard and University Claude Bernard Lyon I, GINECO group France, 69008 - Lyon/FR


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Abstract 812MO


PAOLA-1/ENGOT-ov25 (NCT02477644) is a phase III trial in pts with newly diagnosed, FIGO stage III‒IV HGOC. Adding olaparib to maintenance bev after first-line platinum-based chemotherapy + bev led to a statistically significant progression-free survival (PFS) benefit in pts with advanced HGOC (hazard ratio 0.59; 95% confidence interval 0.49–0.72; P<0.001) (Ray-Coquard et al. NEJM 2019). Recently, the FDA approved olaparib + bev maintenance following first-line platinum-based chemotherapy response in homologous recombination deficiency (HRD) positive pts. We explored ORR for pts with residual disease in PAOLA-1.


Pts with no evidence of disease or clinical complete response (CR) or partial response (PR) after platinum-based chemotherapy + bev received olaparib tablets (300 mg bid for up to 24 months) + bev (15 mg/kg q3w for 15 months in total) or placebo + bev. In pts with evidence of disease (target and/or non-target lesions) and/or cancer antigen-125 (CA-125) ≥2 x upper limit at baseline (assessment following initial therapy), we explored ORR according to GCIG criteria (Rustin at al. IJGC 2011).


Of 806 randomised pts, 216 (27%) had evidence of disease and/or CA-125 ≥2 x upper limit at baseline (Table). RECIST and/or CA-125 ORR was improved with olaparib + bev vs placebo + bev, with the greatest benefit seen in BRCAm pts and in HRD-positive pts (Table). Table: 812MO

N (%) BRCAm population HRD-positive population ITT population
O + B (n=157) P + B (n=80) O + B (n=255) P + B (n=132) O + B (n=537) P + B (n=269)
Evidence of disease (target/non-target lesions) at baseline 28 (18) 19 (24) 49 (19) 32 (24) 129 (24) 73 (27)
Best overall RECIST response CR PR SD 16 (57) 2 (7) 7 (25) 5 (26) 3 (16) 9 (47) 21 (43) 5 (10) 20 (41) 7 (22) 3 (9) 18 (56) 32 (25) 7 (5) 61 (47) 13 (18) 5 (7) 40 (55)
RECIST ORR 18 (64) 8 (42) 26 (53) 10 (31) 39 (30) 18 (25)
Elevated CA-125 at baseline* 6 (4) 5 (6) 10 (4) 8 (6) 28 (5) 17 (6)
CA-125 ORR 5 (83) 3 (60) 7 (70) 5 (63) 10 (36) 5 (29)
Total evaluable population 29 (18) 20 (25) 51 (20) 35 (27) 138 (26) 78 (29)
ORR according to RECIST and/or CA-125 23 (79) 10 (50) 32 (63) 14 (40) 48 (35) 22 (28)

*At least twice upper limit; B, bevacizumab; ITT, intent to treat; O, olaparib; PD, progressive disease; SD, stable disease.


In PAOLA-1, maintenance bev alone achieves a substantial ORR in pts with residual disease after initial therapy. Adding olaparib improved ORRs compared with bev. In both maintenance arms, BRCAm and HRD-positive pts are deriving the greatest benefit.

Clinical trial identification


Editorial acknowledgement

Medical writing support was provided by Catherine Risebro, PhD, and Claire Routley, PhD, of Mudskipper Business Limited.

Legal entity responsible for the study

ARCAGY Research.


ARCAGY Research, AstraZeneca, Merck & Co., and F. Hoffmann-La Roche.


N. Colombo: Honoraria (self), Advisory/Consultancy: Roche/Genentech; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Pfizer; Advisory/Consultancy: MSD Oncology; Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Tesaro; Advisory/Consultancy: BioCad; Advisory/Consultancy: GSK. J. Gantzer: Travel/Accommodation/Expenses: Ipsen; Travel/Accommodation/Expenses: PharmaMar; Travel/Accommodation/Expenses: Chugai. B. Ataseven: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Honoraria (self): Celgene; Honoraria (self): Clovis Oncology; Honoraria (self): AstraZeneca; Travel/Accommodation/Expenses: PharmaMar. G. Scambia: Speaker Bureau/Expert testimony: Clovis Oncology Italy S.r.l; Speaker Bureau/Expert testimony: MSD Italia S.r.l. A. Herrero: Advisory/Consultancy: Roche; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK/Tesaro. P. Sevelda: Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Tesaro; Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Roche. P. Vuylsteke: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: PharmaMar. P. Buderath: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Honoraria (self): AstraZeneca; Travel/Accommodation/Expenses: Tesaro; Travel/Accommodation/Expenses: PharmaMar. C. Pisano: Advisory/Consultancy: Novartis; Advisory/Consultancy: Pfizer; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK/Tesaro. A. El-Balat: Honoraria (self), Advisory/Consultancy: Roche; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Tesaro; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Olympus; Travel/Accommodation/Expenses: PharmaMar; Travel/Accommodation/Expenses: Teva. I.L. Ray-Coquard: Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Agenus; Honoraria (self), Advisory/Consultancy: Advaxis; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): BMS; Honoraria (self), Advisory/Consultancy: PharmaMar; Honoraria (self), Advisory/Consultancy: Genmab; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self), Honoraria (institution), Research grant/Funding (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Honoraria (self), Honoraria (institution), Advisory/Consultancy, Research grant/Funding (self), Research grant/Funding (institution): MSD; Honoraria (self), Advisory/Consultancy: Deciphera; Honoraria (self), Advisory/Consultancy: Mersena; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Merck Sereno; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Novartis; Honoraria (self), Advisory/Consultancy: Amgen; Honoraria (self), Advisory/Consultancy: Tesaro; Honoraria (self), Advisory/Consultancy: Clovis; Advisory/Consultancy: Roche/Genentech; Non-remunerated activity/ies: GINECO; Non-remunerated activity/ies: ENGOT; Non-remunerated activity/ies: GCIG; Non-remunerated activity/ies: European Community; Non-remunerated activity/ies: ESMO; Non-remunerated activity/ies: ASCO; Non-remunerated activity/ies: ESGO; Non-remunerated activity/ies: IGSC; Non-remunerated activity/ies: Inca. Swiss; Non-remunerated activity/ies: Italian, Belgium and German health authorities. All other authors have declared no conflicts of interest.

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